Developing Rectal USPE Measures

NCT02102867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-05

Study results available
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Summary

The purpose of this study is to: (a) adapt existing vaginal USPE items/instruments for evaluation of similar elements of rectal compartment use; (b) develop these scales using 3 distinct semi-solid formulations that represent a range of physicochemical and rheological properties of microbicides that are currently being designed for dual compartment use; and (c) develop novel USPE instruments to capture the experience of product use in the context of receptive anal intercourse (RAI) in both male and female cohorts.

Conditions

  • Microbicide Delivery System Perceptibility and Acceptability

Interventions

OTHER

Gel

10mL

OTHER

Cream

10mL

OTHER

Liquid

10mL

Sponsors & Collaborators

  • ImQuest Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Kathleen Morrow, PhD · The Miriam Hospital: Centers for Behavioral & Preventive Medicine

  • Robert Buckheit, PhD · ImQuest Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-03-31
Completion
2022-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102867 on ClinicalTrials.gov